RCT of an Oral Acne Supplement for Adult Women

NCT06097871 | Completed

• 1 other identifier: NW-CS-03
• Study Type: interventional
• Target: 102
• Locations: 1 country
• Sites: 1

Brief Summary

This study is to assess the efficacy and tolerability of an oral supplement in mild to moderate acne in adult females.

Conditions

Acne

Outcome Measures

Primary Outcomes (1)

• Change in IGA at 12 weeks

  The primary efficacy endpoint is the investigator assessed change from baseline to week 12 in facial acne IGA rating compared to placebo.

  12 weeks

Secondary Outcomes (12)

• Change in IGA at 4 weeks

  4 weeks

• Change in IGA a 8 weeks

  8 weeks

• Change in corneometry measurements at 4 weeks

  4 weeks

• Change in sebumeter measurements at 4 weeks

  4 weeks

• Change in corneometry measurements at 8 weeks

  8 weeks

Study Arms (2)

Nutraceutical Dietary Supplement

EXPERIMENTAL

A novel nutraceutical skin supplement, scientifically formulated to specifically target the multiple underlying causes of acne in women. The supplement is comprised of primary and secondary ingredients, designed to improve skin from the inside out.

Dietary Supplement: Skin Nutraceutical Supplement

Placebo

PLACEBO COMPARATOR

Oral supplement containing non-active ingredients.

Other: Placebo pill

Interventions

Skin Nutraceutical Supplement DIETARY_SUPPLEMENT

The Skin Nutraceutical Supplement is made with Nutrafol's patented Synergen Skin Complex®, which is a blend of proprietary formulation of botanicals with potent anti-inflammatory, anti-stress adaptogenic, antioxidant and DHT-inhibiting properties combined to synergistically combat the multiple underlying factors that compromise skin health. These ingredients include Holy Basil, Maca, Curcumin, and Berberine in combination with other nutrients used to support skin health such as olive extract (20% hydroxytyrosol), konjac root (3% ceramides), vitamin A, B vitamins, and vitamin C.

Nutraceutical Dietary Supplement

Placebo pill OTHER

A placebo pill containing non-active ingredients

Placebo

Eligibility Criteria

• Age: 18 Years - 50 Years
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Females subjects 18-50 years of age.
• Subjects with mild to moderate (non-cystic) acne (8 inflammatory lesions, 10 non-inflammatory lesions).
• Subjects with an IGA score of 2-3
• Subjects with all skin types (normal, oily, etc.)
• Subjects with all Fitzpatrick skin types I-VI.
• Subjects who agree to use only the provided study skin cleansing, moisturizing, and sunscreen products during the study duration.
• Subjects agree not to introduce any new colored cosmetics (lipsticks, eye shadows, facial foundations, blush, powder) on their face.
• No known medical conditions that, in the investigator's opinion, may interfere with study participation.
• Women of childbearing potential must be willing to use a form of birth control during the study. For the purpose of this study, the following are considered acceptable methods of birth control: oral contraceptives, Norplant®, Depo-Provera®, double barrier methods (e.g., condom and spermicide) and abstinence.
• Subjects are dependable and able to follow directions and willing to comply with the schedule of visits.
• Subjects in generally good physical and mental health.
• Able to read, write, speak, and understand English
• Individual (and/or his/her legally acceptable representative, as applicable) has signed the Consent for Photograph Release and ICD including Health Insurance Portability and Accountability Act (HIPAA) disclosure.
• Subject must avoid sun exposure.
• Subject must avoid professional or facial spa procedures during the study.

You may not qualify if:

• Any dermatological disorder, which in the investigator's opinion, may interfere with the accurate evaluation of the subject's skin characteristics, except for the study condition of acne.
• Subjects who are not willing to use the assigned skin care study products to their face as instructed and are not willing to take an oral acne supplement.
• Females who are pregnant, lactating, or planning to become pregnant during the study or within 30 days of study completion. (Subject must document her response in either the source documentation or informed consent/assent forms).
• Subject has a surgery and/or invasive medical procedure planned during the study.
• Subject has observable suntan, scars, nevi, tattoo, excessive hair (including beard, mustache, or goatee), or other dermal conditions on the face that could interfere with study evaluations or confound study results, as determined by the PI or designee.
• Subject has a history of or a concurrent health condition/situation which, in the opinion of the PI, if medically qualified, or study physician, may put the individual at significant risk, confound the study results, or interfere significantly with the individual's participation in the study.
• Subject is an employee/contractor or immediate family member of the PI, Study Site, or Sponsor.
• Subjects with clinically significant unstable medical disorders.
• Subjects who are unwilling or unable to comply with the requirements of the protocol.
• Subjects with any known allergies or sensitivities to the study products.
• Subjects who have a history of a psychological illness or condition that would interfere with their ability to understand and follow the requirements of the study.
• Subjects who have acne nodules/cysts representative of severe acne.
• Subjects who are currently using, planning to use during the study or has used any of the following in the specified time range (based on subject report):
• month prior to Visit 1: Prescription (oral or topically applied on the face) antibiotics, inhaled steroids (except those prescribed for allergies), or hormones (pre- or post-menopausal hormone-replacement therapy; insulin, etc.), or other medications that could make skin more sensitive or have an effect on the skin, as determined by the PI or designee. Oral contraceptives are acceptable.
• month prior to Visit 1: Prescription medication for acne (e.g. doxycycline, minocycline, clindamycin, sulfamethoxazole and trimethoprim \[Bactrim\], tetracycline, erythromycin, azithromycin, or Vibramycin®)

Sponsors & Collaborators

• Nutraceutical Wellness Inc.: lead

Study Sites (1)

Dermatology Consulting Services

High Point, North Carolina, 27262, United States

Location

Related Publications (1)

• Draelos Z, Harper J, Farris PK, Hazan A, Raymond I. A 12-Week Randomized, Double-Blind, Placebo-Controlled Trial for the Efficacy and Safety of a Novel Nutraceutical for Mild-to-Moderate Acne. J Cosmet Dermatol. 2025 May;24(5):e70220. doi: 10.1111/jocd.70220.

  PMID: 40321085 DERIVED

MeSH Terms

Conditions

Acne Vulgaris

Condition Hierarchy (Ancestors)

Acneiform Eruptions; Skin Diseases; Skin and Connective Tissue Diseases; Sebaceous Gland Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Both the subject and the investigator will be blinded to the subject's group allocation. All outcomes will be assessed by the blinded investigator.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: 1-1 randomization to placebo or active treatment

Study Record Dates

• First Submitted: October 16, 2023
• First Posted: October 24, 2023
• Study Start: January 15, 2024
• Primary Completion: July 24, 2024
• Study Completion: July 25, 2024
• Last Updated: September 25, 2024

Record last verified: 2024-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)